BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP(TM) DISTAL FEMUR PLATE 9 HOLES/236MM-RIGHT

    MDR report key: 18839315 · Received March 5, 2024

    Report

    Report Number
    8030965-2024-03250
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    February 20, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K062564
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H6: THE SUBJECT DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. G1: CORRECTED PHYSICAL MANUFACTURER'S NAME AND ADDRESS. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. H3, H6: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: H3, H6: PART:222.254 LOT NO:9665030 RELEASE TO WAREHOUSE DATE: 01 OCT, 2015 MANUFACTURING SITE: WERK MEZZOVICO A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE HAD BROKEN FORM THE MIDDLE. THE BROKEN FRAGMENT WAS RETURNED FOR EVALUATION. WHILE NO ROOT CAUSE CAN BE ESTABLISHED WITH THE AVAILABLE INFORMATION, FACTORS SUCH AS THE AGE OF THE PATIENT, UNDERLYING DISEASE, BONE DENSITY, OR A POSSIBLE EARLY WEIGHT-BEARING, COULD HAVE LED TO FAILURE OF THE IMPLANT. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO POST MANUFACTURING DAMAGE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE LCP-DF 4.5/5 R 9HO L236 SST WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, OSTEOSYNTHESIS REVISION BY RIGHT FEMORAL PLATE. THE PATIENT HAD BEEN TO EMERGENCY DEPARTMENT BECAUSE OF A RUPTURE OF THE PLATE WITHOUT ANY TRAUMA EVENT. THE PLATE WAS IMPLANTED AFTER A FEMUR FRACTURE UNDER A HIP TOTAL PROSTHESIS PROCEDURE. THE FRACTURE WAS NOT CONSOLIDATED. SURGICAL RE-INTERVENTION REQUIRED AND THE PLATE WAS REMOVED. INSTALLATION: LATERAL DECUBITUS/ORDINARY ORTHOPAEDIC TABLE UNDER GENERAL ANESTHESIA. METHODS: RE-OPENING OF THE APPROACH. REMOVAL OF SCREWS, PLATE AND CERCLAGE. CURETTAGE OF PSEUDARTHROSIS AND DECORTICATION. REDUCTION WITH FORCEPS FOLLOWED BY OSTEOSYNTHESIS WITH TWO PLATES, A LATERAL ANATOMICAL METAPHYSEAL PLATE AND AN ANTERIOR PLATE. THE LATERAL PLATE IS FIXED BY LOCKED SCREWS, WHILE THE ANTERIOR PLATE IS FIXED BY PASSING TWO CABLES THROUGH IT, WITH A COMPLEMENTARY CABLE AT THE PROXIMAL END. FILLING OF THE PSEUDARTHROSIS SITE WITH BANK BONE + COLLAPATH AFTER LAVAGE. CLOSURE WITH REDON DRAIN AND SUCTION. CLOSURE PLANE BY PLANE. SKIN STAPLES. DRESSINGS. IMMOBILISATION BY SPLINT WITHOUT SUPPORT FOR THREE MONTHS. POST-OPERATIVE INSTRUCTIONS: AQUACEL/DUODERM DRESSING EVERY 5 DAYS OR EARLIER IF SATURATED, STAPLES REMOVED AT D12. THIS REPORT INVOLVES ONE (1) LCP(TM) DISTAL FEMUR PLATE 9 HOLES/236MM-RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196114 LCP(TM) DISTAL FEMUR PLATE 9 HOLES/236MM-RIGHT PLATE, FIXATION, BONE HRS SYNTHES GMBH 9665030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention